Quality Systems Engineer — Global Compliance & Improvement

Jenavalve Technology Inc; Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Jenavalve Technology Inc. is seeking an Engineer, Quality Systems at Irvine, CA to support the Quality Management System across lifecycle stages.

This role focuses on audits, CAPA, nonconformance, and continuous improvement within a regulated environment. The incumbent will collaborate with Regulatory, Manufacturing Operations, and R&D to implement eQMS enhancements, validate processes, and ensure regulatory alignment with FDA and international standards.

Qualifications

• Bachelor of Science degree in engineering or relevant scientific discipline.
• Minimum of 2+ years of experience in the medical device, pharmaceutical industry, or life sciences technology.
• Experience with Quality Systems, Regulatory Compliance and/or Standards Management.
• Knowledge of 21 CFR Part 820, ISO 13485, ISO 14971.

Responsibilities

• Collaborate with Regulatory, Manufacturing Operations, and R&D to support the Quality Management System and core processes.
• Lead eQMS system enhancements, validation activities, and ensure QMS requirements are embedded throughout product lifecycle.
• Promote quality culture and provide training on quality system fundamentals across teams.
• Lead gap assessments and support quality and compliance initiatives.
• Support evaluation of FDA guidance and international standards for applicability to products.
• Partner with Regulatory Affairs and cross-functional teams to ensure interpretation and implementation of requirements.
• Support root cause investigations for quality nonconformances and implement corrective/preventive actions.
• Assist FDA inspections, Notified Body audits, and internal audits, including timely closure of findings.
• Support innovation and digital transformation by evaluating and implementing modern analytical tools and KPIs.
• Assist in harmonization of quality KPIs across sites globally.

Skills

Communication

Initiative

Hands-on

Attention to detail

Cross-functional teamwork

Risk management

Education

Bachelor of Science in engineering or relevant science

Job description

Jenavalve Technology Inc. is seeking an Engineer, Quality Systems at Irvine, CA to support the Quality Management System across lifecycle stages.

This role focuses on audits, CAPA, nonconformance, and continuous improvement within a regulated environment. The incumbent will collaborate with Regulatory, Manufacturing Operations, and R&D to implement eQMS enhancements, validate processes, and ensure regulatory alignment with FDA and international standards.